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Preoperative intensity-modulated chemoradiotherapy with simultaneous integrated boost in rectal cancer: five-year follow-up results of a phase II study

Jasna But-Hadzic
Jasna But-Hadzic
, 
Anja Meden Boltezar
Anja Meden Boltezar
, 
Tina Skerl
Tina Skerl
, 
Vesna Zadnik
Vesna Zadnik
 y 
Vaneja Velenik
Vaneja Velenik
   | 19 nov 2021
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Article Category: Research Article
Publicado en línea: 19 nov 2021
Páginas: 439 - 448
Recibido: 17 feb 2021
Aceptado: 26 abr 2021
DOI: https://doi.org/10.2478/raon-2021-0028
© 2021 Jasna But-Hadzic, Anja Meden Boltezar, Tina Skerl, Vesna Zadnik, Vaneja Velenik, published by Sciendo
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Figure 1

Prognostic significance of (A) pathologic nodal stage (pN) and (B) total downstaging on 5-year disease-free survival, (C) prognostic significance of surgery procedure on 5-year disease-free survival and (D) overall survival in rectal cancer after preoperative radiochemotherapy and surgery. APE = abdominoperineal excision; LAR = low anterior resection
Prognostic significance of (A) pathologic nodal stage (pN) and (B) total downstaging on 5-year disease-free survival, (C) prognostic significance of surgery procedure on 5-year disease-free survival and (D) overall survival in rectal cancer after preoperative radiochemotherapy and surgery. APE = abdominoperineal excision; LAR = low anterior resection

Figure 2

Time to occurrence of G ≥ 3 adverse events.
Time to occurrence of G ≥ 3 adverse events.

Number of events after median follow-up of 70 months (11–80 m) and 5-year survival

Intention to treat (N = 51) Per protocol (N = 47)
5-year OS* 76.5% 80.9%
5-year DFS 72.5% 76.5%
5-year LC 90.2% 95.7%
Number of events (%) Number of events (%)
OS status
        Alive 38 (74.5) 37 (78.7) *
        Dead 13 (25.5) 10 (21.3)
DFS status
        Alive without disease 37 (72.5) 36 (76.5)
        Local/distant relapse/death 14 (27.5) 11 (23.5)
LC status
        Local relapse - 46 (90.2) 45 (95.7)
        Local relapse + 5 (9.8) 2 (4.3)

Late toxicity after preoperative radiochemotherapy, surgery and adjuvant chemotherapy according to CTCAE version 5.020

G1, n (%) G2, n (%) G3, n (%) G4, n (%) G5, n (%)
Anastomotic dehiscence - 1 (2.1) 3 (6.3) - -
Anastomotic stenosis 4 (10.0) - - - -
Ileus - - - - 1 (2.1)
Hernia 4 (8.3) 1(2.1) 1(2.1) - -
Abdominal or pelvic pain 11 (22.9) 3 (6.3) - - -
Anal stenosis 5 (10.4) - - - -
Fistula - 1 (2.1) 2 (4.2) - -
Bloating 21 (43.8) 3 (6.3) - - -
Constipation 10 (20.8) 4 (8.3) - - -
Diarrhoea 9 (18.8) 5 (10.4) - - -
Faecal incontinence 6 (15.4) 12 (30.8) 3 (7.7) - -
Faecal urgency* 5 (13.2) 1(2.6) - - -
Flatulence 25 (52.1) 6 (12.5) - - -
Haemorrhoidal haemorrhage 1 (2.1) - - - -
Haemorrhoids 3 (6.3) - - - -
Proctitis 1 (2.1) - - - -
Intestinal stoma leak 2 (8.3) - - - -
Dysuria 1 (2.1) - - - -
Urinary frequency 13 (27.1) - - - -
Urinary incontinence 9 (18.8) 4 (8.3) 1 (2.1) - -
Urinary retention 1 (2.1) 1 (2.1) - - -
Urinary urgency 21 (43.8) 1 (2.1) - - -
Ejaculation disorder (n = 20) 5 (25) 1 (5) - - -
Erectile disfunction (n=20) 2 (10.0) 6 (30.0) 2 (10.0) - -
Dyspareunia (n=18) 1 (5.6) 2 (11.1) 1 (5.6) - -
Vaginal dryness (n = 18) 1 (5.6) 3 (16.7) 1 (5.6) - -
Vaginal stricture (n = 18) 1 (5.6) 1 (5.6) 1 (5.6) - -
Treatment-related secondary malignancy - - 1 (2.0) - -
Other** - - - - -

Influence of probable prognostic factors on OS and DFS

Intention to treat (N = 51) Per protocol (N = 47)
Prognostic factor OS DFS OS DFS
Age at diagnosis (≥ 65 years vs. <65 years) ns ns ns ns
Gender (male vs. female) p = 0.044 ns p = 0.064 ns
PS WHO ns ns ns ns
Tumour grade ns ns ns ns
Tumour location (upper/ middle/lower rectal third) ns ns ns ns
MRI + ns ns ns ns
Extramesorectal lymph nodes (positive/negative) ns ns ns ns
Time to treatment(≤ 7w / > 7w) p = 0.045 ns ns ns
Surgery procedure (APE and pelvic exenteration/LAR) p = 0.000 p = 0.013 p = 0.020 p = 0.016
cT stagea ns ns ns ns
cN stagea ns ns ns ns
Decrease in T stage ns ns ns ns
Decrease in N stage ns ns ns ns
Total downstaging ns p = 0.029 ns p = 0.029
pT stage (0-2 vs. 3-4) ns ns ns ns
pN stage (0 vs. +) ns p = 0.044 ns p = 0.019
Ekstramesorectal lymp node removal ns ns ns ns
pCR ns ns ns ns
TRG prognostic group ns ns ns ns
NAR prognostic group ns ns ns ns
Adjuvant chemotherapyb (5-6 / ≤ 4 cycles) ns ns ns ns
Treatment per protocol p = 0.006 p = 0.001 / /

Health-related quality of life analysis: Mean scores comparisons 5 years after treatment with general Slovenian population38 and with EORTC reference values for colorectal cancer patients39 for all scales of EORTC QLQ-C30

Scale 5-year post-surgery mean (SD) General Slovenian population mean (SD) p value* Colorectal reference values mean (SD) p value*
Global health status/QoL 60.8 (26.1) 71.1 (21.4) 0.035 62.1 (23.4) 0.759
Functional scales
         Physical function 78.9 (24.5) 91.8 (14.0) 0.006 83.0 (21.1) 0.285
         Role function 77.4 (26.0) 88.7 (20.1) 0.022 70.4 (32.8) 0.238
         Emotional function 74.7 (25.0) 82.0 (18.5) 0.115 68.9 (24.5) 0.192
         Cognitive function 78.0 (24.5) 90.2 (16.0) 0.009 85.2 (20.4) 0.052
         Social function 78.5 (24.8) 90.9 (17.3) 0.009 76.0 (28.6) 0.629
Symptom scales
         Fatigue 29.4 (23.2) 19.8 (19.8) 0.029 34.7 (28.4) 0.302
         Nausea/vomiting 6.5 (10.3) 3.3 (10.6) 0.097 7.3 (17.2) 0.796
         Pain 21.0 (23.2) 14.5 (20.2) 0.130 24.0 (29.6) 0.575
         Dyspnoea 10.8 (23.4) 5.3 (15.3) 0.204 17.4 (26.3) 0.160
         Insomnia 30.1 (30.3) 19.8 (25.1) 0.067 30.5 (32.6) 0.946
         Appetite loss 12.9 (22.2) 5.3 (15.5) 0.067 19.1 (30.2) 0.256
         Constipation 20.4 (26.8) 6.9 (16.9) 0.009 15.8 (27.9) 0.363
         Diarrhoea 16.1 (22.6) 4.2 (13.6) 0.006 16.6 (27.6) 0.920
Financial problems 22.6 (29.0) 6.6 (17.5) 0.005 13.6 (26.3) 0.059
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